Tony Zappia (Makin, Australian Labor Party, Shadow Parliamentary Secretary for Manufacturing) Share this | Link to this | Hansard source

The Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 primarily implements eight recommendations of the expert panel review of medicines and medical devices which handed down its stage 1 report, which dealt with regulatory frameworks for medicines and medical devices, in March 2015, and its stage 2 report, which dealt with the regulatory framework for complementary medicines and the advertising of therapeutic goods, in July 2015.

Russell Broadbent (McMillan, Liberal Party) Share this | Link to this | Hansard source

Can I just interrupt the member for Makin a moment. The question is that this bill be now read a second time. Thank you, Member for Makin.

Tony Zappia (Makin, Australian Labor Party, Shadow Parliamentary Secretary for Manufacturing) Share this | Link to this | Hansard source

Thank you, Mr Deputy Speaker. I will not repeat my introductory comments, but—

Russell Broadbent (McMillan, Liberal Party) Share this | Link to this | Hansard source

You can, because I would like to hear them again.

Tony Zappia (Makin, Australian Labor Party, Shadow Parliamentary Secretary for Manufacturing) Share this | Link to this | Hansard source

Thank you, Mr Deputy Speaker! The Therapeutic Goods Amendment (2016 Measures No.1) Bill 2016 primarily implements eight recommendations of the expert panel review of medicines and medical devices, which handed down its stage 1 report, which dealt with the regulatory frameworks for medicines and medical devices, in March 2015, and its stage 2 report, which dealt with the regulatory framework for complementary medicines and the advertising of therapeutic goods, in July 2015. The two reports contained 58 recommendations, of which the government, I understand, supported 56. I understand the government proposes additional legislation to deal with other recommendations in that report.

The intent of the expert panel review was to identify areas of regulation of medicines and medical devices that could be streamlined without compromising the safety, efficacy and quality of therapeutic goods available in Australia. The bill establishes a framework for the provision of regulations or legislative instruments that will enable the fast-tracking or expediting of the assessment and approval process of therapeutic goods.

The Therapeutic Goods Administration has existed for over 26 years. It has oversight of a large number of medicines, medical devices and complementary medicines. As at April 2016, the Australian Register of Therapeutic Goods had around 87,000 entries. Over those 26 years, there have been several changes to the TG Act to ensure it continues to be appropriate for the changes occurring in society, and, in 2002, medical devices were included in the act. Australian consumers rely on the TGA to ensure that the health products they use are safe. They put their trust in the TGA assessment, as do health professionals who prescribe, select or recommend the medical products. The implications of a poor assessment of a product can be very serious. There is a balance required between expediting the TGA's process and maintaining the safety, quality and efficacy of products. The reforms proposed by this legislation are substantial and complex. The critical details of the reforms will be in the ensuing regulations and legislative instruments, which we have yet to see.

I note that the bill was introduced by the government with a five-minute second reading speech, which I believe did not do this legislation justice. Furthermore, whilst the government advises that the regulations will be subject to extensive consultations, we do not know what consultations are proposed and with whom. If indeed consultations have already taken place, who was consulted and what were the outcomes? There are too many unknowns, and it is impossible to know whether the balance that is necessary will be achieved. The Senate Standing Committee for the Scrutiny of Bills raised similar concerns about the broad delegation of legislative power and the significance of the matters in the delegated legislation. The committee also highlighted further concerns about strict liability offences, reversal of the burden of proof and abrogation of the privilege against self-incrimination. That is why the bill was also referred to the Senate Community Affairs Legislation Committee.

Whilst we will be supporting this legislation, we do so with several reservations, which I will outline shortly. Australia's Therapeutic Goods Administration rates very well when compared with overseas regulatory authorities. For example, median approval times for new active substances are 391 days, or about five weeks longer than the fastest performing authority, Health Canada. Quoting directly from the expert panel's review:

According to the TGA's key performance indicators report for the period July to December 2014, 100% of new applications were processed within the statutory timeframe of 255 working days.

Whilst making the TGA approval process more efficient is strongly supported, expediting the process should not in any way raise the level of risk to consumers. In the past there have been cases of medical products being found to have serious adverse effects or failing to perform as expected.

In April 2010, the TGA recalled silicone breast implants manufactured by French company Poly Implant Prothese, otherwise known as PIP. The implants had been used in Australia since 1999. Concerns had been raised that the implants had a higher rupture rate. Investigations by French authorities found the manufacturer had been using a cheaper, industrial-grade silicone, which was not approved. I also understand that in 2013 the founder of PIP was sent to prison for four years and received a fine of 75,000 euros. Regulators around the world came to different conclusions and responded with different advice to patients on whether people who had the implants but had not yet experienced problems should have them removed. The TGA states on its website:

These investigations have not found any evidence to suggest that the risks involved with the use of PIP breast implants are any greater than those for any other brand of silicone gel-filled breast implants.

Expert advice provided to the TGA has concluded that the currently available scientific evidence does not support a recommendation to routinely remove (explant) PIP implants from people who do not have any evidence of problems associated with their implants.

However, the French government recommended that 30,000 women in France have the implants removed. I understand that around 500 women in Australia have been part of a class action lawsuit over the implants, with many individual stories from victims who have had to have the implants removed and have been left physically scarred. Symptoms reported include large lumps appearing on the neck and chest, migraines and headaches, nosebleeds and pain. In 2014 there was also a recall of Cereform breast implants made by another French company, CEREPLAS, which had not fully validated the sterilisation process as required.

There was also the faulty DePuy ASR hip replacement, which was implanted in around 5,500 Australian patients. The supply was discontinued in Australia in December 2009, with a worldwide recall in August 2010. The metal ball was found to be grating against its socket, resulting in metal fragments high in cobalt and chromium entering the bloodstream. Many people who had the device implanted suffered from symptoms including severe pain, partial loss of vision and hearing, depression, lethargy and heart problems. Faulty hip and knee devices can leave patients with bone degeneration and metal poisoning, and they may end up confined to a wheelchair or needing limbs amputated. These are very serious medical conditions. More than 13 per cent of the people who had these implants required revision surgery. That surgery comes at an additional cost to the patients and to the health system. As well as the financial costs, surgery is never risk free. It results in time spent in hospital or convalescing. In the case of joint replacements, the patients are more likely to be elderly, and surgery will likely take a greater toll on their body.

Serious adverse effects have also been exposed with respect to medicines. In their submission to the recent Senate Community Affairs Legislation Committee inquiry, the Royal Australasian College of Physicians state:

The TGA has a strong history of identifying safety concerns before other regulators, examples of this include:

We know that patients want access to new medicines and medical products as soon as possible. Additionally, expediting the approval process will have economic benefits for the country. As noted by the expert panel, in 2013-14 Australia's pharmaceutical industry turnover was $23.4 billion, with exports of $3.89 billion. It directly employed about 41,000 people, of which nearly 15,500 were in manufacturing. The complementary medicine sector turns over between $2 billion and $3.5 billion in revenue each year and directly employs about 5,000 people in high-skilled manufacturing positions. Complementary medicines are a rapidly-growing industry sector with huge potential for overseas market growth. The medical device industry is equally important to Australia's economy. Australia's medical device industry has a turnover of around $10 billion per year. In 2013-14, Australia exported medical devices with a value of about $2.1 billion to 167 countries around the world. Australia has more than 500 medical technology companies, and they employ 19,000 people. Medical technology companies operate in a very competitive global market.

Turning to the specifics of this bill, the bill amends the Therapeutic Goods Act 1989. First, it will enable the making of regulations to establish new priority pathways for faster approval of medicines, medical devices, biologicals and conformity assessment certificates in Australia.

Second, it will enable the making of regulations to designate Australian notified bodies that would be able to appraise the suitability of the manufacturing process for medical devices manufactured in Australia and to consider whether such medical devices meet relevant minimum standards for safety and performance. This would be an alternative to the Therapeutic Goods Administration undertaking such assessments.

Third, it will allow certain unapproved therapeutic goods that are currently accessed by healthcare practitioners by applying to the secretary for approval. They will be more easily obtained by practitioners by notifying the secretary within 28 days of having supplied such goods to their patients, rather than requiring prior approval. The amendments would allow the minister to make a legislative instrument specifying which goods would be able to be accessed in this way, by which kinds of healthcare practitioners, and in what circumstances and in accordance with conditions specified in the instrument.

Four, it would provide review and appeal rights for persons who apply to add new ingredients for use in listed complementary medicines. Last, it would remove the requirement for the minister to consult the Therapeutic Goods Committee when making standards for therapeutic goods other than medical devices. The Therapeutic Goods Committee, along with three other committees, were effectively abolished by regulation on 1 January this year. I understand the TGC's role has been spread across other committees. The minister will have the option of consulting any of the other committees, but will not be compelled to do so.

The bill also includes a number of other, mostly minor, measures to provide greater consistency across the regulation of different kinds of therapeutic goods under the act, to reduce regulatory burden, to reduce health risks to the public and to make other minor changes. The reforms are intended to bring new medicines to market more quickly by entering into work-sharing arrangements with comparable overseas regulators, the increased use of assessments done by comparable overseas regulators and the implementation of expedited and provisional approvals.

With respect to medical devices, the reforms also allow for commercial bodies in Australia to be designated to undertake medical device assessments. The reliance on overseas regulators and assessments by designated commercial bodies, whether in Australia or from overseas, is not without risks. As the expert panel state in chapter 3 of their report:

In recent years the European system has been shown to have systemic weaknesses, which has led to concerns about the quality of conformity assessment undertaken by some EU notified bodies. A series of articles published in the BMJ raised a number of issues including:

I understand that there are some 70 such bodies operating currently in the EU. I understand that they are also competing to increase their profits, as one of them quite proudly mentioned in one of their reports. The fact that they are private entities with responsibilities to their shareholders raises the very concerns that are alluded to in the comments that I have just made. What comes first—their priority to their shareholders or their priority to the health and wellbeing of the people who are going to use the products which they have been tasked to assess and approve?

A report produced by the US Food and Drug Administration in May 2012 also found concerns with the European conformity assessment system, asserting that it has resulted in harm to patients through the application of less-stringent assessment standards than those that apply in the US. I quote from that report:

Because of the EU’s lower approval standard and degree of oversight, high-risk devices are more often approved first in the EU than in the US. The lack of valid evidence of effectiveness has several negative effects on patients, however. As shown in this report, the EU’s reliance on limited testing, generally without significant testing in humans, can fail to predict dangerous risks and ineffective treatment in actual use. As a result, approval of devices without a valid demonstration of effectiveness has permitted the marketing of products in the EU that turned out to cause severe harm to patients, either because the testing was inadequate to reveal the device's risks or because use of an ineffective device denied patients access to effective treatments for serious diseases. In addition, the lack of valid data on effectiveness has caused some of the biggest EU countries to delay reimbursement for some approved high-risk devices until a second, sometimes lengthy cost-effectiveness review is completed. In those cases, EU approval of a device does not necessarily mean that it is available to patients there.

The EU system for approving devices has now also come under criticism from the European medical community because of the number of devices that have turned out to be dangerous or ineffective. The medical community has also expressed dissatisfaction with the inconsistent review standards of the private bodies that approve devices in the EU and the secrecy surrounding the device approval process there.

The report goes on to say that the EU is in the process of reviewing its regulation of medical devices and that some notified bodies have had their authority to undertake assessments under the medical device directive withdrawn, while others have had the authority suspended or reduced in scope. Both of those actions suggest that the system does not always work as expected. The EU experience cannot be ignored and should serve as a warning about the risks associated with allowing private entities to undertake assessments. The expert panel also refers to concerns about the US regulatory system for medical devices.

The government also states that, as a result of the reforms, there will be enhanced post market surveillance of medicines and medical devices. How this will be done, and by whom, will be of interest, but it will inevitably require greater resources by either the product manufacturers or the TGA. This is of particular significance, given reports last year that TGA compliance staff had been reduced, that fake pharmaceuticals were being sold to consumers by organised criminal groups, and that the TGA did not have the resources to police this growing problem. Reforms to the regulation of complementary medicines include increasing the information available on the efficacy, introducing statutory time frames for the approval of new ingredients, and adopting a risk based approach to the variations of complementary medicines. There will also be a simplification of therapeutic product advertising regulations, and streamlining of the Special Access Scheme. It seems that there is a push towards self-regulation of product advertising. Again, self-regulation is not without its failings—as we have seen all too often in so many other industry bodies—which, ultimately, have led to the government having to, in some form or another, step in and correct the problems.

Lastly, I also raise concerns that the use of private commercial bodies for assessments will inevitably lead to downsizing of the TGA itself, and could lessen the ability of the TGA to perform its statutory obligations. This is a matter which the expert panel referred to in chapter 7 of their report. In particular, the report stated:

Reductions in de novo evaluations and introduction of abridged assessments for some variations will result in a reduction in NRA staffing needs, primarily highly skilled medical and scientific staff who will be difficult to replace if the need arises, especially quickly. Such a reduction, if significant enough, may undermine the NRA’s capacity to:

•   respond to sudden increases in workload, resulting in less timely evaluations of medicines and medical devices, thereby undermining one of the aims of the Review;

•   respond to emerging public health issues, such as the need to undertake recalls, manage medicine shortages, or manage major non-compliance. In these instances, resourcing would need to be redirected from other core business, which in turn will translate into reduced timeliness and responsiveness; and

•   undertake evaluations of orphan drugs or process applications for access to unregistered medicines in a timely way.

The report also raised concerns that continued investment in IT systems necessary for timely and cost-effective regulatory services may come at the expense of other activities. This is because those systems are likely to have similar costs, even if they end up being used by fewer people. If the NRA's income declines, other activities may be cut to make up the shortfall. These are serious concerns, which have not been adequately addressed. I am particularly concerned by any changes which, effectively, will reduce the ability of the TGA to continue to perform the very valuable work that it has performed over the last 26 years or so.

This is important legislation that enables changes to a complex regulatory system. The changes will mostly be made via regulations that have not been drafted, necessitating further scrutiny of the government's implementation planning once they are available. We accept that new medicines and medical devices are being developed and trialled around the world every day, and that where those products are showing encouraging results consumers want access to them as quickly as possible. If the approval process can be sped up then it should be. But in the rush to get new products onto the market, we should be confident that the people who take them are not placed at any level of increased risk. Once made, these changes will be very difficult to unwind.

This is legislation that affects most Australians. It is legislation that affects an important industry sector. It is legislation that changes longstanding practices of the TGA. The government is asking the parliament to support the legislation by saying: 'Trust us with the regulations.' We know what happens when this government says 'trust us'. In summary, Labor is concerned that the substance of this legislation will be in regulations that we have not yet seen. We therefore reserve our position on the regulations until we do see them. Labor is also concerned about the lack of detail surrounding third-party conformity assessments of medical devices. There is little information provided in this bill into the selection process of third-party conformity assessment bodies. Who will they be? What assessment process will be required of them? What oversight of the process used by the assessment bodies will be undertaken by the TGA itself? What accountability and reporting mechanism should be put in place? We have not seen any of that detail whatsoever. We are simply being asked to trust the government with respect to the regulations or legislative instruments, which effectively are the key to this legislation.

Finally, we have concerns about the details relating to post-market monitoring and what resources will be provided to the TGA for this measure. As I mentioned earlier, we already have some concerns about the scaling down of the TGA itself, which in turn will reduce its ability to carry out other functions. What resources will be provided to the TGA with respect to the post-market monitoring that is expected under the legislation? We do not know. We will wait to see what the details will be once the government provides those regulations. As I have said from the outset, Labor will support this legislation, but we do so with reservations, which I have outlined and which we reserve our right to reassess once we see both the regulations and the legislative instruments that will be brought into this place.

Sharon Bird (Cunningham, Australian Labor Party, Shadow Minister for Vocational Education) Share this | Link to this | Hansard source

I rise today to speak on this important bill, the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016. As did my colleague the member for Makin, I indicate my support for this bill, with a number of reservations. Firstly, I would like to touch on aspects of the bill and what reservations I hold. Secondly, I would like to talk about some important examples where this is a significant local issue in my electorate.

The bill amends the Therapeutic Goods Act 1989. It seeks to do a number of things. It seeks to enable the making of regulations to establish new priority pathways for faster approval of medicines, medical devices, biologicals and conformity assessment certificates in Australia. It also seeks to enable the making of regulations to designate Australian notified bodies that would be able to appraise the suitability of the manufacturing process for medical devices manufactured in Australia and to consider whether such medical devices meet relevant minimum standards for safety and performance, as an alternative to the TGA undertaking such assessments. It seeks to allow certain unapproved therapeutic goods that are currently accessed by healthcare practitioners through a process of applying to the secretary for approval to be more easily obtained by practitioners only having to notify the secretary within 28 days of having supplied such goods to their patients, rather than requiring pre-approval. The amendments would allow the minister to make a legislative instrument specifying which goods would be able to be accessed in this way and by which kinds of healthcare practitioners and in what circumstances, in accordance with conditions specified in the instrument. The legislation will also provide review and appeal rights for persons who apply to add new ingredients for use in listed complementary medicines. It will also remove the requirement for the minister to consult with the Therapeutic Goods Committee when making standards for therapeutic goods other than medical devices. The TGC, along with three other committees, was abolished by regulation effective on 1 January. The TGC's role has been spread across other committees. The minister will have the option of consulting any of the other committees but will not be compelled to.

I acknowledge that the bill includes a number of other, mostly minor, measures which aim to provide greater consistency across the regulation of different kinds of therapeutic goods under the act, reduce regulatory burden, reduce health risks to the public or make other, more minor changes. As I said at the outset, I and Labor support the bill, but we do have reservations about some of the detail, in particular the details of the regulations, which have not been drafted to date, and those around third-party assessments of medical devices. I will not go into those in any detail, because they have been quite clearly outlined by my colleague the member for Makin.

In this debate today, I specifically want to talk about the importance of this sort of legislation to two constituents of mine who represent, I think it would be fair to say, a broader number of constituents across my electorate. Certainly, in their campaigns they have had significant support indicated very broadly in our community.

Firstly, I would like to talk to the chamber about someone who I have talked about in this place before, and that is my constituent Ben Oakley. Where the regulation of medicines and medical devices can be streamlined whilst the safety and quality is maintained, it should be. I have recently been making representation on behalf of Ben and his dad, Michael Oakley, who have been campaigning on the issues surrounding medicinal cannabis. Michael and his son, Ben, came to Canberra on 15 February this year. They came to talk to people about their experiences and the importance of access to medicinal cannabis.

For the information of the chamber, Ben has an incurable neurological disorder, which is known as Stiff Person Syndrome, and he uses medicinal cannabis to manage his condition. When Ben was diagnosed, he was the youngest person in Australia to be afflicted with this condition, which affects about 20 people here. At the time he was triathlon fit; indeed, he was first struck when riding his bike home. He was quite shocked by the impact of that first seizure, given that he was such a young, fit person. Originally Ben came to see me with his dad to talk about the issue of rare diseases. Before he started treatment with medicinal cannabis, Ben had more than 600 seizures, including 61 in a nine-hour period, with one of those spasms lasting more than two hours. Since accessing medicinal cannabis, Ben has had only three seizures in total.

For over two years Labor has called on the government to do more to improve access to medicinal cannabis for people with life-threatening illnesses. In February 2016 the government introduced legislation to amend the Narcotics Drug Act to establish a licensing arrangement for the cultivation, manufacture and supply of medicinal cannabis. At the time , along with Labor, I welcomed this action. Our belief was that it would ensure access to a safe, regulated source of medicinal cannabis from a domestic supplier and we made it clear at the time, as did the then health minister, that medicinal products made from Australian grown cannabis crops could be in use as early as 2017. However, it has taken over a year for any real access to be granted and there is still a long, long way to go.

I am very happy to indicate to the chamber that I am very grateful to the health minister's office—both the former health minister and the current health minister—for the assistance that they have provided to Michael and Ben Oakley to try and work through the complicated and confusing process of legally obtaining medicinal cannabis. Their doctor, however, has only just been granted prescriber status and now he, in conjunction with the hospital pharmacy, needs to find an overseas supplier and courier in order for Ben to receive the treatment he desperately needs. The process is confusing and time consuming and there is still no steady supply. Prescribing doctors and their pharmacies need to go in search of this product and try and find a suitable overseas supply for use in Australia.

Following Ben's visit, the Leader of the Opposition wrote to the Prime Minister urging him to identify an overseas source and regulate its supply in Australia to improve consistency of supply and give patients confidence that they are using safe products. This would also remove some of the complicated and confusing requirements that exist within the existing arrangements. The Leader of the Opposition offered to work with the Prime Minister and support any changes necessary to achieve this. I hope the Prime Minister responds positively to that invitation. After witnessing the battle that Ben and his family have been through to try and obtain medicinal cannabis legally, I support this bill's intention to streamline the regulation of medicines and medical devices, while maintaining safety and quality, regulation of medicines and medical devices. Fast access to new medicines and medical devices is critical for people whose health and wellbeing worsens each day they wait for new treatments to be approved.

At the beginning of my contribution to this debate, I indicated there were two people I had met for whom these issues are important. I want to go now to the second case that has been brought to my attention. We do need to ensure that patients have fast access to life-saving medicines and new treatments and that these treatments are affordable. I recently met with Melissa Bowyer from my electorate. Melissa's son Riley was diagnosed with Periodic Fever Syndrome or PFS in April last year. This is a rare auto-inflammatory disease that causes frequent fevers at 40-plus degrees, along with body pains in the back, the legs and the abdomen. As a result, Riley has missed out on a great deal of preschool as well as many other activities that other young children his age should out enjoying. Melissa detailed for me the impact that this has had on her family. She has had to resign her job in order to care for Riley.

Melissa is a member of Rare Voices Australia which launched the Fair for Rare campaign earlier this year that seeks to raise awareness in the community of rare diseases. Melissa has found that access to vital health services and treatment for rare diseases is scarce and scattered across the country and that this significantly impacts on families. Rare Voices has been working, including with Labor's shadow minister for health, to push for answers around the Life Saving Drugs Program review and to raise awareness of the importance of having a clear and timely funding pathway for rare disease treatments—a pathway that is, indeed, Fair for Rare.

Nicole Millis, Rare Voices Australia's executive office, said just one new medicine was funded under the Life Saving Drugs Program in 2016 and concerned that changes had been made to the scheme without consultation. In Senate estimates in February, departmental officials were unable to explain the delays in reforming the program with the review being under review for two years. The government's lack of consultation with Rare Voices is in stark contrast to Labor's approach. At Labor's health policy summit, Nicole Millis was invited to participate and she said that:

...it was important that RVA was part of these discussions, being a voice for all Australians living with rare disease. Our invitation to the event arguably shows our increasing political presence. As can be seen in the National Health Policy Summit Communique, RVA was successful in bringing rare disease into the discussion around social inequality.

Importantly Nicole was also able to personally engage and thank shadow health minister Catherine King and many other leading Labor figures who have provided political support to RVA's ongoing call for transparency and resolution of the Life Saving Drugs Program review and access to rare disease treatments.

It is clear that streamlining the approval process to ensure that people like Ben Oakley and Riley Bowyer can access the treatments they need to improve their quality of life is of very real importance to them and their families. I particularly thank both of these constituents and their families. Melissa brought along her mum on the day she came to see me, as well. You can see the impacts and the stress, indeed the distress, that these sorts of rare diseases can cause for these families. It takes so long for somebody to correctly identify the disease that you have, and that process in itself takes an enormous toll on families. To have them then go into a system where accessing the treatments they need becomes a long a tortuous road is not good enough. I commend the Rare Voices campaign and I sincerely thank my own local constituents Ben and Michael for campaigning on medicinal cannabis and Melissa and her young son Riley for campaigning to get better access to treatments for rare diseases. I can assure them that I will be continuing to campaign on that in this House as well.

Emma McBride (Dobell, Australian Labor Party) Share this | Link to this | Hansard source

I started my pharmacy training in 1994 and first registered as a pharmacist some 20 years ago. In my working life as a community and hospital pharmacist in Australia and overseas I have witnessed much change. Work in health is fast paced and breakthroughs in treatment save lives. With conditions that we were grappling to understand when I was starting out a pharmacist, such as HIV, in 2017 people are living close to normal lives due to modern treatments. Medicines such as statins—HMG-CoA reductase inhibitors—the new blockbuster drugs of the 1990s, are now routinely prescribed by GPs in practices across Australia.

The Australian healthcare system is founded on the principles of universal access. Governments have a duty to ensure equity in the financing and provision of healthcare services. We all have a stake in the health of our nation—those of us who are sick or care for someone who is sick; those of us who live with and manage chronic and complex conditions; those of us who despair for those who are suffering; and those who live each and every day in the hope of a cure. Medicines are important. Access to medicines saves lives.

I am pleased to support the Therapeutic Goods Amendment (2016 Measures No.1) Bill 2016 because ultimately it will mean improved access to medicines, a change which is better for all of us. However, I do so with some reservations. This bill will amend the Therapeutic Goods Act to support a number of recommendations made by the expert panel review of medicines and medical devices led by Professor Lloyd Sansom. The expert panel's purpose was to consider whether and where reforms to the Australian regulatory system could benefit Australia and Australian health consumers. The review, rightly, found that the standards of the Therapeutic Goods Administration are internationally respected and its regulatory functions are well carried out. But in health we strive for continuous improvement and constantly ask how we can and should do better.

The recommendations adopted in this bill would improve the functioning of the TGA and support access to medicines. Labor supports the bill and I am pleased to speak this bill, though with some reservations. The Therapeutic Goods Administration Act 1989 and its associated regulations provide a number of avenues through which unapproved therapeutic goods may be supplied, including the Authorised Prescriber Scheme and the Special Access Scheme —the SAS. An unapproved therapeutic good means any medicine not entered in the Australian Register of Therapeutic Goods, any medical device not entered in the register, any biological not entered, or a therapeutic good already entered in the register that is used beyond the conditions of its marketing approval. The SAS is currently categorised into category A, life-threatening, and category B, non-life-threatening.

I will start by discussing recommendation 24 of the Sansom review, which relates to category A and category B Special Access Scheme medications, which are handed out on a daily basis to outpatients of Wyong Hospital. The bill supports recommendation 24 of the review, which stipulates that the current criteria and processes for category A SAS patients remain unchanged. However, it proposes that certain low-risk category B medicines should receive automatic approval, subject to a number of safeguards. As a hospital pharmacist and former member of the Central Coast Local Health District Drug and Therapeutic Committee, I understand the importance of robust decision-making processes and approval pathways for medicines and medical devices. I am also aware of the necessity for the regulations, protocols, policies, procedures and guidelines that safeguard their use. However, I am acutely aware of the unnecessary delays, treatment interruptions and distress to patients and their families that can and do occur because of the administrative burden to access these medications—the paperwork, the lengthy phone calls and the extensive consultation and liaison required for drugs which in many cases are low risk—medication such as Midodrine, used in the treatment of orthostatic hypotension. The delay in commencing this medication due to current SAS processes can delay effective treatment and increase the patient's hospital stay. That outcome is not in the best interests of the patient or our health service.

The TGA reports that it receives around 20,000 SAS category B applications each year. Only 0.3 per cent of these applications are rejected. Regularly submitting and resubmitting paper-based SAS category B forms for medications that have an established history of use for a given indication and do not risk public safety only increases the administrative burden for clinicians and, as I have pointed out, can delay or interrupt necessary treatment. I welcome this commonsense change for certain low-risk category B medications. I would also welcome a move away from the current paper-based system and the development of an online system for SAS applications and notifications.

This bill also supports recommendation 26 of the Sansom review, proposing to enable more timely access to unapproved therapeutic goods for patients under the Authorised Prescriber Scheme and reduced regulatory burdens on clinicians.

The AP Scheme allows approved prescribers to prescribe a specific therapeutic good to a class of patients under their care. The current process involves assessment of the clinical justification by both the TGA and either a human research ethics committee or a specialist medical college. There are no changes proposed to the HREC or specialist college role in the AP Scheme, but the TGA will provide increased guidance to assist in the delivery of those roles.

The bill also supports recommendation 27 of the Sansom review, which proposes that the government develop a more comprehensive postmarketing monitoring scheme for medicines and medical devices, including better integration and analysis of information from datasets including the medical benefits scheme; the establishment of registries for high-risk implantable devices; the implementation of an alert scheme for newly registered medicines to encourage reporting of adverse events; allowing the electronic reporting of adverse events; and improving collaboration with overseas regulators. Central to this is better integration and timely analysis of available datasets, including analysis of matched, de-identified data from the PBS, MBS, eHealth, hospital records, private health insurance and other available datasets.

I note, in particular, the contribution of the Pharmaceutical Society of Australia, which says:

… it is essential that we move towards a holistic, nationally-coordinated and outcomes-focussed approach to undertaking pharmacovigilance activities … pharmacovigilance encompasses the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

I support the PSA in their assertion that Australia has the ability to lead the world in the collection of accurate and timely information on new medicines. If we are to build efficiencies in the health sector and improve health outcomes for patients, integration of datasets is vital.

I particularly welcome changes that will encourage the reporting of adverse events for newly registered medicines. The TGA states:

No therapeutic product is ever completely risk free. Some risks may be known when a medicine or medical device is first entered on the … Register … However, some information only comes to light after more people use the products.

Twelve per cent of all medical admissions and 20 to 30 per cent of all hospital admissions in the population aged 65 years and over are estimated to be directly attributable to medication misadventure. Everyone wants the doctor who sees them in the ED to have the most up-to-date information. Everyone wants the pharmacist who reviews their medication to have the most up-to-date information. I particularly welcome changes that will encourage the reporting of adverse events for newly registered medicines, whilst noting that the government has proposed strengthened postmarketing monitoring and surveillance. We have not seen all the details, so it is not possible to determine if those enhanced measures will be adequate. We also do not know how the Australian notified bodies will be chosen or how they will be monitored.

Medicines matter. Last year I met Jude, a young boy from Hamlyn Terrace. Jude has a double mutation of the cystic fibrosis gene, along with other complex health conditions. His mum, Caron, is a nurse and midwife. Along with his dad, Matthew, they do an exceptional job loving and caring for Jude. Their lives were turned upside down when Jude was diagnosed with CF. Jude is two years old. They are Jude's voice. They are the voice of other children and families who share their journey. They told me how important Medicare and the PBS are for them and how heartbroken they were when the advisory committee deferred the listing of the drug Kalydeco, which will change the life of Jude and around 30 other children across the country under the age of five living with this disease. Their lives are forever changed as a result of the recent PBS listing of Kalydeco, and I thank the Minister for Health and the government for doing the right thing for Jude's family and other families. Jude is responding well to the treatment, which he had access to within one week of the announcement. His mum, Caron, tells me he is a bundle of energy—running and playing like any other two-year-old. He no longer has to spend all his energy focused simply on breathing.

Like Jude, I met Evie and her mum, Sonia, when the Kalydeco kids came to Canberra. Evie's life could have been very different. Currently, Evie takes 15,500 tablets each year, needs 1,100 hours of physiotherapy and nebulised medicines, is connected to a feed pump for 3,350 hours a year, requires 730 insulin injections and misses between 40 and 60 days of school. Then there are Evie's blood tests, MRIs and other monitoring. Fast access to new medicines is critical for people whose health and wellbeing worsens each day they wait for treatment. Access to medicines matters. They can change the lives of people like Jude and their families.

Last week I meet with Darryl and Heath from the Australian Federation of AIDS Organisations. The AFAO is the peak body for the HIV community response. They provide leadership, coordination and support to the national policy, advocacy and health promotion response to HIV-AIDS. Among the many important matters raised by this community-led advocacy group was access to PrEP. PrEP, or pre-exposure prophylaxis, can reduce the risk of infection of HIV by up to 90 per cent. While originally developed to treat HIV infection, it is now also used to prevent the infection in those at high risk of the virus.

PrEP is one of the most significant advances in the continuing effort to eliminate the transmission of HIV. Modern treatments for HIV both dramatically improve the outlook for people with the virus and help to prevent its transmission. As a hospital pharmacist working with the Central Coast Local Health District Sexual Health Clinic and their medical director, Dr Debbie Allen, I was involved for many years with the work being done to advance the cause of those living with HIV.

The Holden Street Sexual Health Clinic in Gosford is a trial site for PrEP. It will cater to 50 patients and is one of 20 sites across NSW which saw some of the 3,700 Australians taking part in EPIC-NSW—Expanded PrEP Implementation in Communities in NSW. The trial will provide clinical data that will hopefully see PrEP on the PBS in the coming years. While the PBS will likely make a decision on including PrEP this year, Australians are already accessing the drug. GPs across Australia are assisting their patients with access to medication through the personal importation scheme. But this does not treat all Australians equally. We should be ensuring that people at high risk of HIV have access and that existing state based trials are expanded with additional trial spaces.

Australia should be proud of the level of care, treatment, research and prevention of HIV that we have supported for decades. Better access to PrEP is the next step in responding to HIV, and bills like this go some way to ensuring that Australians are all able to access the very best quality medications and health care in a timely manner. I welcome the meeting between the PrEP stakeholders and the chair of the PBAC held last month, which gave organisations a valuable opportunity to express their views about the listing of this medication or this treatment. This is another important step in advancing this important cause.

Fast access to new medicines is critical for people whose health and wellbeing worsens each day they wait for access. As a pharmacist working in community and hospital pharmacy over the last 20 years, I know that medicines are important, I know that medical treatments can change lives and I know that fast access for people who have conditions that worsen each day is critical. Labor will be supporting this bill; however, we do so with some reservations.

Mike Freelander (Macarthur, Australian Labor Party) Share this | Link to this | Hansard source

I commend the comments by the previous speaker, the member for Dobell. I agree entirely. Call me old and cynical, but 38 years as a medical practitioner before coming here taught me to be suspicious of streamlining proposals and efficiency measures touted by governments, state and federal. In the case of Liberal and coalition governments, it was good practice to set the bulldust detectors to Spinal Tap's 11 on the 10-point scale. With Labor governments as a medico you had to sometimes comfort yourself however with the simple thought that, 'At least they mean well.' But in every case—and I am sure I am not alone in this—you seldom went far wrong in assuming that the departmental officialese of 'efficiency, economising and enhanced productivity' being parroted by the minister was code for either cost cutting or cost shifting back onto unsuspecting public patients.

As a newly minted member of parliament, I have tried to modify those personal prejudices and curb the ingrained and battle-hardened scepticism. The trouble is, though, I keep talking to patients and medical colleagues and those discussions sometimes lead pretty quickly back to that darkest of all dark questions: what are they really up to? So I still tend to wonder how seemingly nice or anodyne-sounding ideas such as those contained in this Therapeutic Goods Amendment (2016 Measures No.1) Bill 2016 might work out in practice.

This bill, of course, takes a very sensible steps towards facilitating the more rapid take-up of new medicines and other medical advances. Our medical armamentarium has improved dramatically over the last 200 years. As a doctor, the number of medications available to treat common candidates such as asthma, epilepsy, cardiovascular disease and infection are so numerous that it is almost impossible to know them all and all their side effects. Increasingly, we are faced with new drugs targeted to specific and sometimes rare disorders. These new medications can be lifesaving, as already mentioned in the case of Kalydeco for certain forms of cystic fibrosis. New classes of drugs, such as the biologics, are very expensive but can also be very effective for some of the rare immunological disorders and for some forms of cancer.

Increasingly, demand for medications for some disorders in old age is rampant. Some of the newer cancer medications such as those for lung, bowel and prostate cancer are in constant demand, and new treatments are being developed all the time. Genetic disorders such as cystic fibrosis can now for the first time be treated with drugs directly targeted to the underlying metabolic disorder. The next generation of these drugs is already in the pipeline.

Most of the research into the effectiveness and safety of these medications occurs in Europe, Japan or the United States. Data about the effectiveness and side-effects profiles are available from overseas institutions which are very reputable. Australia does not have the research ability to undertake strict double-blind trials on all these new medications. Our health consumers and medical professionals are well aware of the availability of new treatments and regularly review information from other countries about new modalities and will actively seek out these treatments, often available through various internet sites. That certainly happened to me in practice. Therefore, it is important that we are able to approve access to, recommend and prescribe these treatments as soon as we can where warranted. Sometimes it has taken a very long period of time for medication that has been approved overseas to be approved in Australia. Ondansetron is one that comes to mind. It is a medication used for severe vomiting due to severe illness and chemotherapy.

More generally, though, these days I recognise that there are two, not three, truisms about efficiency measures in health. The first is that Liberal and coalition governments are not the most wholehearted defenders of the universality principle and public health spending to walk the earth. They have form that dates back to their early opposition to Medibank, its repeal and their reluctant acceptance of the general public's continued support for Medicare bulk-billing and proper protection from the potentially crippling costs. This I do not believe is a contentious point.

Three days after last year's 2 July election, a somewhat chastened Prime Minister rightly observed in relation to those legitimate expectations on the issue of public trust:

That—

the election result—

is a very clear lesson. We have to do more to reaffirm the faith of the Australian people in our commitment to health and to Medicare.

He said the coalition had to:

… work harder to rebuild or strengthen the trust of the Australian people in our side of politics when it comes to health. There is no question about that.

I am sure that the Prime Minister actually believes that. What I am less sure of is that all those who sit behind him or on the Treasury bench, including two former health ministers—Mr Abbott and Mr Dutton—do.

But let's move on. The second truism is less contentious but should not for that reason go unmentioned. It is, of course, that all governments must deal with the rising cost of medicines and health care. Those rising costs have to be met from increased levies or taxes or through savings in other areas. That inevitably means that all governments are always on the lookout for savings in health. How could it be otherwise with health expenditure by governments, state and federal, now in excess of $108 billion per annum, of which the Commonwealth's share is $66 billion?

Medicare Benefits Schedule spending has risen by more than 60 per cent annually over the last two decades, and medical costs have been on average the fastest-growing component of the CPI over the last 15 years. Ross Gittins in his usual insightful way picked up on this policy dilemma in one of his excellent columns earlier last week. As Gittins argues—and I firmly agree with him:

… the intergenerational reports make it clear health will be by far the fastest growing.

That's not so much because of ageing as because advances in medical technology are hugely expensive, and it's quite unrealistic to imagine that Australian voters will settle for anything less than gaining subsidised access to the latest and best technology …

Add 'earliest' to Gittins' list and you can see immediately what this bill is trying to do, even if I have some current qualms about how it is trying to do it. Gittins goes on—and I still think he is on the right track—to say:

Our politicians … need to be brave and tell voters the truth: if they want ever more and better healthcare then, as with everything else, they'll have to pay more for it—in the form of, say, regular increases in the Medicare levy.

And yes, the last Labor government was brave enough to increase the Medicare levy to help fund the NDIS; and no, the electorate apparently did not react as if it was the end of civilisation. I also agree with Gittens that part of the solution is cutting out waste and efficiency. Again, this bill is highly pertinent, and where I think there is a strong measure of agreement across the chamber is that the introduction of new medicines, medical devices and procedures should not be unduly impeded, particularly when they can be life-saving. Gittens goes further—and I think this is where some of those opposite might be a little less sanguine about his proposed course of treatment. Gittens makes for me the not unreasonable point that those who want over and above the basic service provided by government should usually pay for it themselves. Taxes should not be levied or expended to finance, entrench or sustain inequality. That brings me to what I consider the third truism of Australian health policy, and back to the detailed elements of this bill.

From the time I considered giving up my career in medicine and standing for the seat of Macarthur, it seemed to me that the problem with government health policy was the lack of an overarching plan. Related to this was the sometimes haphazard or clumsy way in which policy was made and implemented. If you look at the health bills before this House over the last couple of weeks—some are admirable in their own way—you get a sense of government nibbling at the edges of policy, rather than trying to foster a broader consensus about how $108-plus billion of government spending annually on health care might be more effectively deployed. Perhaps what we are seeing that this week is no more than an incident of how the drafting resources of the Office of Parliamentary Counsel line up with the parliamentary timetable. But it does play into a wider unease I think we might all share about the delivery of health care, and the formation of health policy more broadly, with this government. The first bills I spoke on in this place were the National Cancer Screening Register Bill 2016 and the National Cancer Screening Register (Consequential and Transitional Provisions) Bill 2016. The object of those bills was unexceptional enough, and even welcome—you did, though, need to ignore the fact that the proposed register was long overdue, and might have been extended to a national register for breast cancer and other cancers. What was really concerning to many, and even slightly dodgy, was that the bills as first presented trespassed on privacy rights, and that the proposed register had already been flogged off—in advance of parliamentary approval—to a private body not noted for its experience or expertise in the field of handling medical records.

I was reminded of those concerns when I tuned into the Health Report on Radio National, as I do quite often, to hear doubts being expressed about unexplained delays in implementing a national strategy to deal with type II diabetes, and the delay in implementing promises made at the time of the election about insulin pumps for children with type I diabetes. Diabetes is a huge problem in Australia and costs our economy over $14 billion a year. Acting Deputy Speaker Hogan, you would think that a strategy developed to prevent diabetes would not be bogged down in a government working group for the best part of two years; you might expect it would have a bit of a higher priority and some urgency—so too with this bill. We have here a bill introduced late last year to streamline the processes for getting new medicines and medical devices onto the Australian market, a worthy idea but not a new one. The bill encompasses the work of the Sansom review established in 2014—which reported in 2015—to which the government responded some two years later, in September 2016. There has also been a Senate inquiry by the Standing Committee on Community Affairs, which recommended a comprehensive review of the system for registration and subsidisation of medicines. So the government and the policymakers, in effect, have been working on this for the best part of at least three years, even if you ignore any work done prior to the Sansom inquiry getting underway. It is at that point that you start to wonder about whether the process, for reasons unexplained, has gone a bit off the rails; if the wheels have not totally fallen off, they are certainly displaying a few disconcerting wobbles.

For starters, the current bill was introduced prior to the government responding to the community affairs committee report—something you think might easily have been done. That is something the Senate also seems to have thought a bit remiss, because the substance of this bill was promptly referred off to the Community Affairs Legislation Committee by the Senate Standing Committee for Selection of Bills. That is no huge drama of itself, although you do wonder if that might not have happened if the process had been handled more adroitly or in a more conciliatory fashion. I also note that this House is being asked to consider the merits of the bill without the benefit of the work or findings of the Senate Community Affairs Legislation Committee, which is not due to report for a few days yet. The other Senate committee to look at the bill is the Standing Committee for the Scrutiny of Bills. The task of that committee is to ensure that legislation, amongst other things, does not unduly trespass on individual liberties; and does not undermine the rule of law or parliamentary sovereignty by making rights and liberties unduly dependent on administrative powers, inappropriately delegating legislative powers, or insufficiently subjecting the exercise of legislative power to parliamentary scrutiny. The scrutiny of bills committee reported its findings on the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 —which are quite numerous for such a short bill—to the Senate on 8 February and asked for a detailed response by 23 February. One arrived on 2 March.

The scrutiny of bills committee has now considered the minister's response and it has commented in a number of ways: firstly, that the explanation memorandum was insufficiently candid and informative; that more significant elements of the assessment regime should be included in the primary bill and not in delegated legislation; and that authorised persons under the act have defined qualifications or skills. The committee also commented that processes by an advisory body under the proposed act be subjected to legislative control; and that defences available to manufacturers accused of providing false or misleading information or documents unduly cast the onus on the Therapeutic Goods Administration. These are matters which I expect will be addressed in another place, and need not be fatal to the bill. But they are significant matters and, as with the case of the national cancer screening registry bills that I referred to earlier, the net effect is that you are a little less confident than you might otherwise have been about supporting these proposals. If we are to make the sort of progress required in advancing the quality of medical care by guaranteeing value for money, we must ensure that the policy processes are working a little more smoothly than may be the case in the health portfolio. The health portfolio seems to follow much of the other government legislation, in that it is thought-bubble policymaking. There is no overarching plan; there is no real plan for a health policy for all Australians in 2017. Let us hope the new minister can bring some of his well-known and not inconsiderable talents to the task. I wish him well. We support this bill, but I have some concerns about the whole process of policy and health policy determination, and the real mishmash of ways that it is being organised by this government.

Tim Hammond (Perth, Australian Labor Party) Share this | Link to this | Hansard source

I too rise to speak to the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 and I thank my honourable members for their contribution to this debate. This bill is principally a measure to cut red tape. It consolidates, streamlines and reorganises a number of the rules, regulations and processes around the approval of therapeutic goods in a way that is aimed to get medicines and other goods to patients when they need them. I aim to speak with some more specificity in a moment about the merits, or otherwise, of the measures in the bill, but let's start at first principles.

From the consumer affairs perspective, there are significant product safety considerations when assessing for approval any new therapeutic good. Therapeutic goods are products used in humans in connection with preventing, diagnosing or treating an illness or injury; testing a person; affecting conception; pregnancy testing; or replacing or modifying parts of the anatomy. They range from paracetamol to condoms, prescription drugs and prosthetic feet. But product safety concerns do not exist in a vacuum. When a patient is dying or suffering pain, the calculus changes—and so the role of the Therapeutic Goods Administration in approving and regulating these goods, which requires specialist knowledge and skill as well as a robust regulatory environment.

In terms of the mechanics, therapeutic goods are assessed by the TGA and then entered into the Australian Register of Therapeutic Goods before they can be sold. TGA takes a risk based approach to regulation, focusing on high-risk medicines like prescriptions, which must be registered. Lower risk therapeutic goods such as sun screens or vitamins may be listed if the applicant certifies that the claims about the effectiveness of the product are accurate and that certain standards are met regarding ingredients, quality, labelling and packaging. So the TGA relies upon applicant certification with a compliance regime for low-risk therapeutic goods but does a direct evaluation for high-risk goods. It should be noted too that certain programs allow products that are not on the register. For example, the Special Access Scheme allows import or supply of unapproved goods for a single patient. This is linked to the single patient's doctor. The TGA monitors products that are approved. This includes risk management plans; collecting reports of adverse events or reactions; audits; and environmental scanning for safety issues.

I would now like to go through some of the provisions of this bill individually because I think it is important to consider the balance between product safety and patients' therapeutic needs. This bill amends the Therapeutic Goods Act 1989 primarily to support some of the key recommendations of the Sansom review of medicines and medical devices, which reported in 2015. The review's intent was to reduce unnecessary duplicative or ineffective regulation without jeopardising the safety or quality of therapeutic goods. The review also aimed to position Australia to respond to emerging global trends. Two reports were provided in 2015. The first report had 32 recommendations, including to expand pathways for sponsors to seek approval, the enhancement of post-marketing monitoring and improvements to the transparency and predictability of TGA decision-making. The second report focused on complementary medicines and advertising and made 26 recommendations, including around improving market approval and advertising requirements and streamlining the advertising framework. The then health minister responded to the report formally last year, agreeing to a majority but not all of the recommendations in those two reports.

Whilst Labor is supportive of the aims of this bill, some of the specifics are probably not ideal. Fast access to new medicines and medical devices is critical for people whose health and wellbeing worsens each day, and then they are required to wait for access. Furthermore, duplication of effort is wasteful and, again, should be avoided where it can. That is why Labor will be supporting the bill. Labor will also be watching very closely the development of regulations as yet undrafted—and I will come back to that—and it is important that regulatory regimes around consumer safety are monitored on an ongoing basis.

Specifically, the bill will ensure greater consistency in the regulation of different classes of therapeutic goods; streamline the approval process for new medicines, medical devices, biologicals and conformity assessment certificates in Australia, providing patients with faster access to these goods and medicines; enable regulations to be made so Australian notified bodies would be able to appraise the suitability of the manufacturing process for medical devices that are manufactured in Australia; enable Australian notified bodies to consider whether such medical devices meet relevant minimum standards for safety and performance; allow certain unapproved therapeutic goods that are currently accessed by applying to the secretary of the Department of Health to be more easily obtained by practitioners; adopt a risk based approach to the management of variations to medicines by allowing certain kinds of variations that do not impact the quality, safety or efficacy of medicines to be made by notification to the TGA rather than requiring the approval of the secretary; allow practitioners the opportunity to notify the secretary within 28 days of having supplied therapeutic goods to their patients rather than requiring pre-approval to allow the TGA to develop a more comprehensive post-market monitoring scheme for medicines and medical devices ; provide review and appeal rights for people who apply to add new ingredients for use in listed complementary medicines; and enable the cancellation of registered or listed therapeutic goods from the register if the sponsor of the goods has supplied false or misleading information in relation to their application. This ought to protect consumers and, hopefully, reduce breaches of the Australian Consumer Law in relation to therapeutic goods.

The bill will also serve to strengthen post-marketing powers, recalls and notifications and the obtaining of information about therapeutic goods. This is particularly important from a consumer affairs/public safety point of view. The bill will allow the secretary to reinstate therapeutic goods to the register that were cancelled if the goods were cancelled for non-payment of annual charges and if, principally, the sponsor has paid the charge; develop criteria for developing and identifying certain therapeutic goods that are not in the register that may be able to be supplied to patients other than those who are gravely ill by notification to the TGA rather than, as is the case currently, requiring the prior approval of the secretary; require manufacturing licence holders to provide information or documents upon request; allow conditions on the inclusion of kinds of medical devices in the register to be either prescribed by regulation or set out in a legislative instrument made by the minister to bring the situation in relation to conditions for medical devices in line with 'registered' or 'listed'; ensure the capacity to refuse to list on the Australian Register of Therapeutic Goods—

Mark Coulton (Parkes, Deputy-Speaker) Share this | Link to this | Hansard source

Order! The debate is interrupted in accordance with standing order 43. The debate may be resumed at a later hour and the member for Perth will be given an opportunity at that time to complete his contribution.